AIMHI v1.0
Research type
Research Study
Full title
Evaluating the Cara Plus App: A Randomised Controlled Trial of an Artificial Intelligence Mental Health Intervention for Psychological Distress (AIMHI)
IRAS ID
367927
Contact name
Elizabeth Calcott
Contact email
Sponsor organisation
Spectrum Wellness Limited (Spectrum.Life)
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
This study will explore how different types of digital mental health platforms are used by adults with mild to moderate symptoms of anxiety and/or low mood. Digital mental health platforms are increasingly available, but more research is needed to understand how they are used, how acceptable they are to people, and how symptoms change over time when using them.
The study will involve adults aged 18 years and over and will take place entirely online. After providing informed consent and completing screening questionnaires, eligible participants will be randomly allocated to one of two groups. One group will be given access to a digital mental health platform in the form of Cara Plus, which is software intended to manage symptoms of anxiety and/or depression in adults who experience mild to moderate symptoms of anxiety and/or depression. The other group will be given access to publicly available online mental health information and support resources. For participants, both options will be described using the neutral term “digital mental health platforms”.
Cara Plus provides conversational guidance presented as text and interactive exercises within a chat-based interface. These may include guided activities such as simple breathing tasks, short reflective prompts, and other evidence-based techniques to support emotional regulation. The information provided supports self-management of symptoms and is not intended to guide clinical decisions or replace professional judgement.
Participants will be asked to engage with the digital mental health platform available to them over an eight-week period. All participants will also be asked to complete short online questionnaires about anxiety, low mood, and wellbeing at several time points during the study.
Participation is voluntary, and participants may withdraw at any time without giving a reason. Some questionnaires ask about mental health and may cause temporary emotional discomfort for some people. Measures are in place to minimise risk, including eligibility screening and providing information about appropriate sources of support throughout the study.
The findings from this research will help inform the evaluation and responsible development of digital mental health platforms.
REC name
South East Scotland REC 02
REC reference
26/SS/0027
Date of REC Opinion
2 Apr 2026
REC opinion
Further Information Unfavourable Opinion